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Home » Avadel Sues FDA Claiming Botched Approval Process for Narcolepsy Drug Lumryz
Avadel Sues FDA Claiming Botched Approval Process for Narcolepsy Drug Lumryz
Avadel Pharmaceuticals has sued the FDA and HHS for holding up review and approval of its Lumryz narcolepsy drug after making administrative errors in the approval process, including delaying the review 10 months beyond the legal limit and requiring an unneeded patent certification.